Abstract: In Brazil, the legal framework for approving biosimilars was established in 2010 and the first biosimilar product was approved in 2015. In June 2024, RDC 875 introduced new provisions, including the use of international reference drugs and the possibility of waiving non-clinical and comparative clinical studies under certain conditions. By September 2025, ANVISA had […]
Abstract: The physicochemical stability of Azacitidine Accord, a pyrimidine analogue antineoplastic agent, was assessed after reconstitution with cold water for injection (WFI) and storage in original glass vials and polypropylene (PP) syringes at different temperatures. At 2°C–8°C, stability was observed for 3 days in both containers. At -20°C, stability was maintained for 60 days regardless […]
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Abstract: This study assessed the physicochemical stability of Bortezomib Accord 2.5 mg/mL solutions for subcutaneous and intravenous injection under various storage conditions. Bortezomib 2.5 mg/mL solutions for subcutaneous injection remained stable for up to 84 days in punctured vials and polypropylene syringes under light-protected conditions at […]
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of undiluted Cabazitaxel Accord in punctured original vials and after dilution with 0.9% sodium chloride solution or 5% glucose solution in non-PVC bottles at the concentrations 0.1 mg/mL and 0.26 mg/mL. Methods: Punctured […]
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of undiluted Carboplatin Accord 10 mg/mL in punctured original vials and polypropylene (PP) syringes as well as after dilution with commonly used infusion fluids in polyethylene (PE) bottles at two different concentrations (0.3 […]
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of undiluted Cisplatin Accord 1 mg/mL in punctured original vials and polypropylene (PP) syringes as well as after dilution with 0.9% sodium chloride solution in polyethylene (PE) bottles at two different concentrations (0.01 […]
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of Cytarabine Accord 100 mg/mL in punctured original vials and after dilution with 0.9% sodium chloride solution in polyolefine (PO) bags stored at room temperature. Methods: Cytarabine Accord 100 mg/mL was diluted with […]
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of Docetaxel Accord infusion solutions 0.3 mg/mL and 0.9 mg/mL in non-PVC-bags either pre-filled with 0.9% sodium chloride solution or 5% glucose solution for up to 98 days. Methods: Docetaxel Accord 20 mg/mL […]
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of Epirubicin Accord 2 mg/mL concentrate in original glass vials after first opening and after transfer to polypropylene (PP) syringes as well as diluted Epirubicin Accord solutions 0.1 mg/mL, 1.6 mg/mL in 0.9% […]
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of Doxorubicin Accord 2 mg/mL concentrate in original glass vials after first opening and after transfer to polypropylene (PP) syringes as well as diluted Doxorubicin Accord solutions (0.05 mg/mL, 1.6 mg/mL) in 0.9% […]
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of Etoposide Accord concentrate in punctured vials and after dilution to the concentrations 0.2 mg/mL, 0.4 mg/mL and 0.45 mg/mL in commonly used infusion fluids and containers. Methods: Test solutions were prepared aseptically […]
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To assess the physicochemical stability of fludarabine in punctured original vials and after dilution with 0.9% sodium chloride solution at three different concentrations (0.25 mg/mL, 1.2 mg/mL, 6.0 mg/mL) in commonly used infusion containers. Methods: Test solutions were […]
